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Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Information source: Ewha Womans University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Bupropion, Escitalopram (Drug); Escitalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Ewha Womans University

Official(s) and/or principal investigator(s):
In Kyoon Lyoo, MD, PhD, MMS, Principal Investigator, Affiliation: Ehwa W. univ hospital

Summary

The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.

Clinical Details

Official title: Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome:

Change from Baseline in Depressive Symptom Scores at 8 Weeks

Change from Baseline in Depressive Symptom Scores at 4 Weeks

Change from Baseline in Depressive Symptom Scores at 1 Week

Secondary outcome:

Number of Participants with Adverse Events

Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks

Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach

Number of Participants with Adverse Events

Number of Participants with Adverse Events

Changes in Fatigue Severity Scale scores

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women aged between 20 and 65

- Diagnosis of major depressive disorder (MDD) as assessed by the Structured Clinical

Interview for DSM-IV (SCID-IV)

- Individuals who provided written consent for participation.

Exclusion Criteria:

- Presence of any major physical or neurological illness (e. g., head trauma, epilepsy,

seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)

- Diagnosis of any Axis I disorder other than MDD or presence of symptoms requiring

hospitalization

- Intelligence quotient (IQ) below 80

- Contraindications to magnetic resonance imaging (e. g., pacemaker implantation,

claustrophobia, etc.)

- Unstable medical illness or other abnormalities observed at the screening or

laboratory tests

- Women who are pregnant, breastfeeding, or planning pregnancy

- Allergy or tolerance to the clinical trial medication

- Presence of any physical illness that contraindicates the clinical trial medication

(e. g., epilepsy, history of uncontrollable narrow-angle glaucoma)

- Use of psychoactive medications that may affect brain imaging findings

Locations and Contacts

Seoul National University Hospital, Biomedical Research Institute, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: March 2009
Last updated: April 9, 2014

Page last updated: August 23, 2015

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